BioSpace News Archive

Vericel Corporation today announced that its development partner, MediWound Ltd., received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for NexoBrid, a potential treatment for eschar removal in adults with deep partial-thickness and/or full-thickness burns.

BioT announces today a $6.5 million Seed Round financing led by Bridges Israel, together with North First Ventures, and XT Hi-Tech.

Moderna, Inc. today announced new results from in vitro neutralization studies of sera from individuals vaccinated with the Moderna COVID-19 Vaccine showing activity against variants of SARS-CoV-2.

Align Technology, Inc., a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, announced the recipients of its Invisalign® ChangeMakers program, launched in partnership with National 4-H Council.

Interventional Systems announced MicromateTM, the world’s smallest robot for percutaneous procedures, received its FDA 510(k) clearance, allowing the robotics company to operate in the USA.

Deep 6 AI, the leader in artificial intelligence (AI)-based clinical trial acceleration software (CTAS), today announced significant growth with the addition of key customer wins and an expanding executive leadership team

Glycomine, Inc., a biotechnology company focused on developing new therapies for orphan diseases, today announced the publication in Molecular Genetics and Metabolism of a key finding from a natural history study of phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG), a rare pediatric orphan disease

Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, received a positive opinion on European Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis (ALS).

Venatorx Pharmaceuticals today announced that Mary Beth Dorr, Ph.D. has joined the Company as Vice President, Clinical Science.

MedPro Systems and its Compliance Advisory Services team today announced a partnership with PharmaCertify, the compliance training division of NXLevel Solutions, to help Life Sciences organizations implement more effective and cohesive compliance programs.